Screening for Hepatitis C and Hepatitis B in Inpatients: A Toronto Viral Hepatitis Care Network (VIRCAN) Collaboration

Who is this study for? Patients undergoing screening for viral hepatitis
What treatments are being studied? Rapid Point-of-Care Testing
Status: Unknown status
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Currently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Adults aged 18 years or older at time of consent

• Patients admitted to GIMIUs at TGH or TWH

Contact Information
Primary
Brett Wolfson-Stofko, PhD
brett.wolfson-stofko@uhnresearch.ca
4163404800
Backup
Camelia Capraru
camelia.capraru@uhnresearch.ca
4163404800
Time Frame
Start Date: January 2021
Completion Date: July 2022
Participants
Target number of participants: 2920
Treatments
No Intervention: Conventional Serum Testing
Participants will be screened by conventional HCV antibody (anti-HCV) serology and if screen positive, a second sample will be collected and tested for HCV RNA using a standard commercial assay.
Experimental: Rapid Point-of-Care Testing
Participants will be screened using the OraQuick® Rapid Anti-HCV Point-of-Care Test (OraSure) and if screen positive, an additional whole blood sample will be collected and tested for HCV RNA using Xpert® HCV RNA (Cepheid) point-of-care testing and confirmed using a standard commercial assay.
Related Therapeutic Areas
Sponsors
Leads: Jordan Feld

This content was sourced from clinicaltrials.gov

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